Exercise to Improve Brain Health in Older African Americans
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorRutgers, The State University of New Jersey
About this trial
The goal of this clinical trial is to test the effects of different types of exercise on brain health and Alzheimer's risk in older African Americans.
Specifically, the main question\[s\] it aims to answer are:
* What is the effect of a Cardio-Dance Fitness (CDF) vs. a Strength, Flexibility, and Balance (SFB) intervention on a cognitive marker of Alzheimer's risk, generalization? * What is the effect of the CDF vs. SFB intervention on a fMRI biomarker of Alzheimer's, neural flexibility, and do improvements in neural flexibility mediate improvements in generalization? * Do ABCA7 genotypic variations moderate the efficacy of the CDF vs. SFB intervention for reducing Alzheimer's risk?
Participants will undergo-- at baseline and post-test-- health assessments, cognitive tests, and structural and functional magnetic resonance imaging (fMRI), and a blood-draw to assess Alzheimer's risk biomarker levels.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
self-identify as either African American or Black;
be age 60 or older;
able to speak, read, and understand English;
available over the study period; independently ambulatory (i.e., not needing a wheelchair, walker, or cane);
Disqualifiers
color-blindness (because some of our tasks utilize color as a cue);
any diagnosed neurological disorder (including headaches and peripheral neuropathy); diagnosed or self-reported non-neurological conditions that likely affect MTL outcomes, such as, major depressive disorder (or a Geriatric Depression Scale-Short Form score ≥ 5), schizophrenia, delusional disorder, schizoaffective disorder or significant psychiatric symptoms that could impair the completion of the study (e.g., psychosis), substance-related and addictive disorders (or treatment in past five years), chemotherapy or radiation treatment for cancers, planning to undergo general anesthesia during the study period;
exercise contraindications, such as, orthopedic complications, myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year, current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or another cardiovascular event, and uncontrolled hypertension with resting systolic or diastolic blood pressures > 180/110 mmHg.
Trial design
Design model
Parallel
Treatments tested in this trial
Cardio-Dance Fitness
BehavioralThis is an aerobic cardio-dance fitness exercise class in a social context with aerobic intensity assessed by heart rate monitoring throughout the class. Participants will meet three times a week for approximately 60 minutes per session, over 24 weeks (approximately 6 months).
Strength, Flexibility & Balance
BehavioralThis intervention will serve as a stringent, structurally equivalent, active comparator to the CDF intervention, identical in duration, frequency, and social contact except for the content of this non-aerobic intervention. SFB will involve non-aerobic activity with strength, flexibility, and balance training.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Cardio-Dance FitnessExperimental treatment 1 intervention
Group B: Strength, Flexibility & BalanceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Generalization Performance on the Concurrent Discrimination and Transfer Task
The Concurrent Discrimination and Transfer Task (a task that indexes generalization, the ability to apply past learning to novel task demands) will be administered at baseline, and then following the intervention (6-months). The main outcome from this task is the number transfer errors. A higher score indicates worse generalization.
Time frame
Changes from baseline to six months2
Generalization Performance on the Acquired Equivalence Task
The Acquired Equivalence Task (a task that indexes generalization, the ability to apply past learning to novel task demands) will be administered at baseline, and then following the intervention (6-months). The main outcome from this task is generalization accuracy. A higher score indicates better generalization.
Time frame
Changes from baseline to six months3
Medial Temporal Lobe Neural Flexibility
Medial Temporal Lobe Neural Flexibility is a measure of synchrony via fMRI resting-state analyses in the hippocampus and other medial temporal lobe brain regions for encoding new memories. Flexibility is quantified as the number of times a node displayed a change in community assignment, normalized by the total possible number of changes; this will be computed for each of our seven regions of interest in the medial temporal lobe. A higher score indicates greater flexibility. The flexibility of the MTL network as a whole was then computed as the mean flexibility over all nodes.
Time frame
Changes from baseline to six monthsOther outcomes
1
Exploratory Outcome: AB 42/40
The ratio of 42 to 40 amino acid-long amyloid β, a marker of plaque pathology, will be examined as an exploratory outcome. Lower values indicate more AB 42/40 pathology.
Time frame
Changes from baseline to six months2
Exploratory Outcome: p-tau181
Phosphorylated tau 181, a marker of AD-related tau phosphorylation and secretion, will be examined as an exploratory outcome. Higher values indicate more tau pathology.
Time frame
Changes from baseline to six months3
Exploratory Outcome: p-tau231
Phosphorylated tau 231, a marker of AD-related tau phosphorylation and secretion, will be examined as an exploratory outcome. Higher values indicate more tau pathology.
Time frame
Changes from baseline to six months4
Exploratory Outcome: Neurofilament-light Chain
Neurofilament-light chain (NfL) is a neuronal cytoplasmic protein; its levels increase in plasma and cerebrospinal fluid proportional to the degree of axonal damage in a variety of neurological disorders, including Alzheimer's disease. Higher values indicate greater axonal damage.
Time frame
Changes from baseline to six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rutgers, The State University of New Jersey
Lead sponsor
Göteborg University
Collaborator
University of California, Irvine
Collaborator
Source ClinicalTrials.gov